To read the letter to the Centers for Disease Control and Prevention, click here.
Excerpt: HHS has failed to issue even one of these annual reports required by law during the nearly four years you have been Secretary. It also means that the 2009 annual report is now more than 1,000 days overdue.
To read the letter, click here.
Excerpt: While we are disappointed that neither you nor anyone else from the NECC could make themselves available to brief committee staff, the committee must proceed with the investigation. We expect that you will cooperate in this matter.
Excerpt: During initial discussions with committee staff on October 12, 2012, FDA officials said that the NECC responded about a month after the warning letter assuring regulators that the firm was in compliance with good compounding practices.
Excerpt: The committee is investigating whether any remedial measures were taken after this inspection and why the NECC was able to continue operating in this manner more than six years after the fact...
Excerpt: We will be meeting with FDA, CDC and others that may provide insight into the details surrounding this outbreak and the prevention of future outbreaks. Given this continued interest, we ask that you preserve all documents and communications that may be relevant to understanding how the product was contaminated and distributed as well as the business practices of the NECC in general.